[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"symptomatic-aortic-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:symptomatic-aortic-stenosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100493901","structured-shared-decision-making-for-patients-undergoing-savr-or-tavr-100493901",false,"NCT05711186","Structured Shared Decision Making for Patients Undergoing SAVR or TAVR","Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial","TOGETHER","Inclusion Criteria:\n\n1. Age ≥ 70 years\n2. Symptomatic severe aortic stenosis defined by an aortic valve area ≤1.0 cm2 or an aortic valve area indexed to body surface area \\\u003C0.6cm2\u002Fm2\n3. Both SAVR and transfemoral TAVR as reasonable treatment options based on heart team decision\n\nExclusion Criteria:\n\n1. Life expectancy \\\u003C1 year irrespective of valvular heart disease\n2. Inability to provide informed consent\n3. Participation in another clinical trial with an active intervention","ALL","70 Years",{"count":20,"type":21},140,"ESTIMATED","INTERVENTIONAL",[24],"NA","Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk. While TAVR and SAVR share some of the benefits and risks, they importantly differ with regards to invasiveness, time to recovery, hemodynamics, as well as options for re-intervention and possibly valve durability. An early benefit of TAVR may be offset by late risks. Therefore, current guidelines of the European Society of Cardiology recommend an integration of patient values and preferences for the selection of the treatment modality.\n\nThe objective of the TOGETHER trial is to investigate the efficacy of a structured shared decision making approach (SDM) to improve patient-centered outcomes for the choice between SAVR and TAVR.\n\nTOGETHER is an investigator-initiated, randomized, open-label, single-center clinical trial. A total of 140 patients referred for treatment of symptomatic severe aortic stenosis and deemed to undergo TAVR or SAVR according to heart team decision will be randomized in a 1:1 ratio to structured SDM or usual care.",[27,28],"Aortic Valve Stenosis","Symptomatic Aortic Stenosis",[28,27,30,31,32,33,34],"SAVR (Surgical Aortic Valve Replacement)","Shared Decision-Making","TAVR (Transcatheter Aortic Valve Replacement)","TAVI (Transcatheter Aortic Valve Implantation)","Decision Support Techniques","RECRUITING","2026-05-07",{"date":38,"type":39},"2026-05-08","ACTUAL",{"date":41,"type":39},"2023-04-17",{"date":43,"type":21},"2027-12-31",{"name":45,"class":46},"Insel Gruppe AG, University Hospital Bern","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100428649","pivotal-study-of-the-vienna-transcatheter-self-expandable-aortic-valve-se-system-100428649","NCT04861805","Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System","A Two -Stage First in Human (FIH) Feasibility \u002F Pivotal Study of the Vienna Aortic Valve SE System","VIVA","Inclusion criteria:\n\n1. Male or Female\n2. Age ≥ 65 years at time of consent\n3. Women of non-childbearing potential\n4. Severe degenerative calcific native aortic valve stenosis with the following criteria assessed either by resting or dobutamine stress TTE:\n\n   1. Aortic valve area (AVA) \\\u003C 1.0 cm2 or AVA index ≤ 0.6 cm2\u002Fm2 and\n   2. Jet velocity \\> 4.0 m\u002Fs or mean gradient \\> 40 mmHg\n5. Symptomatic aortic stenosis (AS), defined as a history of at least one of the following:\n\n   1. Dyspnea that qualifies at NYHA class II or greater\n   2. Angina pectoris\n   3. Cardiac syncope\n6. Subject is considered at intermediate or high risk for surgical valve replacement based on at least one of the following:\n\n   1. EuroSCORE II ≥ 4% along with assessment of frailty, major organ system dysfunction, and procedure-specific impediments, in accordance with scientific guidelines\n   2. Agreement by the Heart Team that subject is at moderate to high operative risk of serious morbidity or mortality with surgical valve replacement.\n7. The local Heart Team deems the patient to be eligible for transfemoral TAVI.\n8. Perimeter-based aortic annulus diameter between ≥ 18 and ≤ 29 mm measured by computed tomography (CT) analyzed by a core lab.\n9. Adequate iliofemoral access with either:\n\n   1. At least one side with minimum vessel diameter ≥ 6.0 mm and acceptable level of vessel calcification and tortuosity for safe placement of the introducer sheath, as analyzed by a core lab, OR\n   2. At least one side with minimum vessel diameter ≥ 5.5 and no significant calcification or severe tortuosity for safe placement of the introducer sheath, as analyzed by a core lab.\n10. Patient (or legal representative) understands the study requirements and the treatment procedures and provides written informed consent.\n11. The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.\n\nExclusion Criteria:\n\nCardiovascular System:\n\n1. Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves.\n2. Evidence of an acute myocardial infarction (MI) ≤ 30 days prior to screening or IMD implantation (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and\u002For troponin elevation).\n3. Patient has had a cerebrovascular stroke or TIA within the past 90 days implantation prior to screening or valve implantation.\n4. Patient has a hypertrophic obstructive cardiomyopathy.\n5. History of any therapeutic invasive cardiac procedure (including balloon aortic valvuloplasty) within 30 days prior to screening or IMD implantation (except for pacemaker implantation which is allowed).\n6. Untreated clinically significant coronary artery disease requiring revascularization at the screening visit.\n7. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \\\u003C 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.\n8. Patient with cardiogenic shock manifested by low cardiac output and hemodynamic instability and vasopressor dependence, or mechanical hemodynamic support\n9. Patients with clinically significant conduction abnormalities (clinically significant sinus bradycardia, sinus block or pauses, clinically significant atrioventricular (AV)-block \\>I) at screening and at time of IMD implantation.\n10. Patient has severe peripheral vascular disease:\n\n    1. including aortic aneurysm defined as maximal luminal diameter \\> 5 cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick \\[\\> 5 mm\\], protruding or ulcerated atheroma in the aortic arch) or\n    2. symptomatic carotid or vertebral disease or successful treatment of carotid stenosis within 30 days prior to screening or IMD implantation.\n11. Patient with iliofemoral vessel characteristics that would preclude safe passage of the introducer (both sides), as analyzed by a core lab:\n\n    1. severe calcification,\n    2. severe tortuosity (\\> two 90-degree bends),\n    3. diameter \\\u003C 6 mm, in patients with acceptable levels of calcification and acceptable levels of tortuosity\n    4. diameter \\\u003C 5.5, in patients with no calcification and no significant tortuosity, OR\n    5. subject has had an aorto-femoral bypass\n12. Patient with active bacterial endocarditis within 6 months prior to screening or IMD implantation.\n13. Patient has (echocardiographic\u002F CT and\u002For MRI) evidence of intra-cardiac mass, thrombus or vegetation.\n14. Patient has a pre-existing prosthetic heart valve in any position (Note: mitral ring is not an exclusion).\n15. Patient has severe mitral regurgitation, severe aortic regurgitation or severe tricuspid regurgitation, moderate or severe mitral stenosis.\n16. Patient has a need for emergency surgery for any reason at time of screening or IMD implantation.\n\n    General:\n17. Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. patient with contraindication to oral antiplatelet therapy)\n18. Patient with renal insufficiency (eGFR \\\u003C 30 ml\u002Fmin per the Cockcroft-Gault formula) and\u002F or renal replacement therapy and\u002F or has serum creatinine level \\> 3.0 mg\u002FdL or 265 µmol\u002FL replacement therapy at the time of screening\n19. Patient with significant pulmonary disease (FEV1 \\\u003C 30%) or currently on home oxygen\n20. Severe pulmonary hypertension (e.g., pulmonary artery systolic pressure ≥ 60 mmHg)\n21. Patients with evidence of an active systemic infection or sepsis.\n22. Patient has a known hypersensitivity or contraindication to contrast media, bovine tissue, nitinol (titanium or nickel), contraindication to oral antiplatelet therapy (aspirin, ticlopidine or clopidogrel) or heparin.\n23. Patient has a haemoglobin \\\u003C 9 g\u002FdL, platelet count \\\u003C 50,000 cells\u002Fmm3 or \\> 700.000 cells\u002Fmm3, or white blood cell count \\\u003C 1.000 cells\u002Fmm3, history of bleeding diathesis or coagulopathy\n24. Patient has peptic ulcer disease or history of gastrointestinal bleeding within the 3 months prior to screening or IMD implantation.\n25. Patient refuses blood transfusions.\n26. Patient has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrolment (i.e. the time of informed consent).\n27. Patient is pregnant or breast feeding.\n28. Severe dementia (resulting in either inability to provide informed consent for the study\u002Fprocedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).\n29. Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the patient from appropriate consent or adherence to the protocol required follow-up exams.\n30. Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint (excluding observational studies).","65 Years",{"count":58,"type":21},267,[24],"This is a prospective, single arm, multicenter study in an cohort of up to 267 patients (up to 100 Roll-ins and 167 patients implanted per protocol) symptomatic patients with severe aortic stenosis who will be followed up for up to 5 years.",[28],[63,64,65,66,67],"heart disease","aortic valve","SSAS","symptomatic severe aortic stenosis","heart valve","2025-06-25",{"date":70,"type":39},"2025-06-29",{"date":72,"type":39},"2023-07-03",{"date":74,"type":21},"2030-10",{"name":76,"class":77},"P+F Products + Features GmbH","INDUSTRY",31,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":47},"100270690","phase-4-transcatheter-aortic-valve-replacement-single-center-registry-in-chinese-population-100270690","NCT02803294","Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population","THE TORCH TRIAL：Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population","TORCH","Inclusion Criteria:\n\n* Patients with symptomatic aortic stenosis\u002Fregurgitation\n* Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n* The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.\n* Patients are technical and anatomical eligible for interventions\n\nExclusion Criteria:\n\n* A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: Aspirin Heparin (HIT\u002FHITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media\n* Subject refuses a blood transfusion.\n* Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.\n* Life expectancy is less than one year","18 Years",{"count":89,"type":21},2000,[91],"PHASE4","The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.",[28],"2021-07-14",{"date":96,"type":39},"2021-07-15",{"date":98,"type":4},"2016-06",{"date":100,"type":21},"2027-07",{"name":102,"class":46},"Second Affiliated Hospital, School of Medicine, Zhejiang University"]